Reg Affairs Spec
Education and Experience:
- Bachelor's Degree in Pharmacy or Life Science
- 2-3 years regulatory experience, or combination of higher education/less experience
- Or substitution of equivalent relevant work experience
Knowledge, Skills and Abilities:
- Broad regulatory affairs experience
- Good interpersonal skills
- Good knowledge Global Regulatory Affairs Procedures
- Proven ability to work effectively in a team
- A good knowledge of a number of country specific clinical trial application procedures Expert knowledge of ICH and global regulatory guidelines
- Familiar with computers and their applications
- Good organizational and planning skills
- Must be able to work autonomously with minimal supervision
- Planning skills
- Mental skills required in areas of reading and interpretation of data, numeracy, language, analytical, investigative, verbal and written communication, customer contact, attention to detail, multiple project tasking